Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005839
Status:
COMPLETED
Last Update Posted:
2015-06-08
First Post:
2000-06-02
Brief Title:
Oxaliplatin Plus Capecitabine in Treating Patients With Metastatic or Recurrent Solid Tumor
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
A Phase I Study of Oxaliplatin in Combination With Capecitabine in MetastaticRecurrent Solid Tumors
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of oxaliplatin combined with capecitabine in treating patients who have metastatic or recurrent solid tumors
PURPOSE Phase I trial to study the effectiveness of oxaliplatin combined with capecitabine in treating patients who have metastatic or recurrent solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose of capecitabine when administered in combination with oxaliplatin in patients with metastatic or recurrent solid tumors II Determine the toxicities of this treatment regimen in this patient population
OUTLINE This is a dose escalation study of capecitabine Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14 Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Patients are followed for disease progression and survival
PROJECTED ACCRUAL A total of 12-15 patients will be accrued for this study
OUTLINE This is a dose escalation study of capecitabine Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14 Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity Patients are followed for disease progression and survival
PROJECTED ACCRUAL A total of 12-15 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-T99-0005 | US NIH GrantContract | None | httpsreporternihgovquickSearchU01CA062505 |
| U01CA062505 | NIH | None | None |
| CHNMC-PHI-25 | None | None | None |
| CHNMC-IRB-99130 | None | None | None |